Topo 2 alpha test FDA approved

Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 17 No 3
Volume 17
Issue 3

TOP2A FISH pharmDx assay has received FDA approval for use as an adjunct to existing clinical and pathological information in determining the prognosis for patients with relatively high-risk breast cancer.

ROCKVILLE, Maryland-Dako’s TOP2A FISH pharmDx assay has received FDA approval for use as an adjunct to existing clinical and pathological information in determining the prognosis for patients with relatively high-risk breast cancer.

It is the first approved test for assessing clinical breast cancer tissue specimens for amplifications and deletions of the topoisomerase 2-alpha gene.

This information aids physicians in evaluating the prognosis for breast cancer patients, since patients with normal topo 2-alpha status have a better outcome than patients with topo 2-alpha gene amplifications or deletions.

The test is suitable for breast cancer patients who are premenopausal or for whom tumor characteristics, such as tumor size or lymph node involvement, suggest a higher likelihood of tumor recurrence or decreased survival.

Topo 2-alpha appears to be a molecular target for the pharmacologic action of anthracyclines, with implications for use of these agents, the Danish-based company said. In a new analysis of the BCIRG 006 trial data, anthracyclines were beneficial only in the subset of patients who had co-amplification of HER2 and the topo 2-alpha gene (see Oncology News International January 2008, page 1).

Recent Videos
Breast oncologist Jade E. Jones, MD, says she tries to send patients with BRCA-mutant HR-positive TNBC to clinical trials that use PARP inhibitors.
Following progression on a CDK4/6 inhibitor, ascertaining the endocrine sensitivity of HR-positive/HER2-negative disease may inform sequential treatment.
T-DXd improved progression-free survival over standard chemotherapy among patients with HR-positive/triple-negative breast cancer in DESTINY-Breast04.
The use of chemotherapy trended towards improved recurrence-free intervals in older patients with high-risk tumors as determined via the MammaPrint assay.
Use of a pharmacist-directed resource appears to improve provider confidence and adverse effect monitoring for patients undergoing infusion therapy.
Reshma L. Mahtani, DO, describes how updates from the DESTINY-Breast09, ASCENT-04, and VERITAC-2 trials may shift practices in the breast cancer field.
Multidisciplinary care can help ensure that treatment planning does not deviate from established guidelines for inflammatory breast cancer management.
Related Content